Senior Engineer, Quality Engineering

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 130,000 - 190,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI, is seeking an experienced Quality Assurance leader to support commercialization programs. The role focuses on qualification, cleaning validation, process validation and CPV within GMP and cGMP frameworks.

You will mentor QA team members, review validation documentation, and collaborate with cross-functional groups to ensure compliant, scalable manufacturing processes for biologics and gene therapies.

Qualifications

• Bachelor's degree in a science field is required.
• 15+ years of experience in cGMP-regulated manufacturing, specifically in validation-related roles.
• Strong knowledge of GMP regulations (21 CFR Part 210/211, EU Annex 11/15, ICH Q7, 21 CFR Part 11).
• Excellent attention to detail and organizational skills.
• Ability to multi-task and prioritize with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.

Responsibilities

• Serve as QA subject matter expert on qualification, cleaning validation, process validation and CPV, including guidance and approval of validation activities.
• Draft, review, and approve procedures to support quality systems for qualification and validation.
• Mentor QA team members in quality engineering functions and audits.
• Collaborate with cross-functional teams to review internal and vendor data for validation activities.
• Support deviations, change controls, and CAPAs related to validation.
• Develop and implement periodic reviews for validated systems and CPV procedures for commercial manufacturing.
• Provide support for audits and documentation reviews.

Skills

Quality Assurance

Validation

GMP Regulations

Documentation

Communication

Education

Bachelor's degree in Science

Tools

Microsoft Word

Microsoft Excel

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

This position within the Quality Assurance department will support ongoing programs for commercialization at Arrowhead. A key function of the position will involve providing leadership and guidance in principles of qualification, cleaning validation, process validation and continued process verification (CPV) in support of commercialization activities at Arrowhead.

Generally, the position will support continued development and maintenance of quality systems supporting Good Manufacturing Practices (GMP) within the organization. Functions of this position will include serving as the Quality Assurance subject matter expert in qualification/validation, cross-functional interaction with internal departments to establish and/or update associated procedures/processes, review/approval of product lifecycle and validation documentation, performing validation assessment of changes and deviations for GMP systems and processes.

Responsibilities

• Serve as the Quality Assurance subject matter expert on qualification, cleaning validation, process validation and CPV. This includes providing guidance, review, and approval of activities such as system requirements engineering, process design, risk assessments, and supporting validation documentation. For cleaning and process validation, provide support in establishment of supporting documentation and templates including risk assessments (for product-contact equipment, process, materials, and CQAs) and parameter classification.
• Draft, review, and approve procedures in support of quality systems for qualification and validation.
• Serve as a resource to mentor Quality Assurance members in Quality Engineering functions (e.g., department procedures, audits, cleaning validation, equipment qualification, process validation, validation assessments, CPV, etc.).
• Work with cross-functional teams in the review and approval of internal and vendor-generated data and documentation in support of validation, qualification, and commissioning activities.
• Provide support for the issuance, review, tracking, and approval of internal deviations, change controls, and CAPAs as related to validation activities and assessments.
• Support the development and implementation of periodic reviews for validated systems/processes including establishment of CPV procedures for commercial manufacturing.
• Provide secondary review of registration batches to evaluate and assess any systemic issues.
• Prepare documentation and provide support for internal and external audits.
• Other duties, consistent with the position, as assigned.

Requirements

• A bachelor’s degree, or higher, in a science field.
• Bachelor’s degree with 15+ years of experience working within cGMP-regulated manufacturing, specifically in validation-related roles in manufacturing and/or quality.
• Working knowledge of GMP regulations (21CFR Part 210/211, EU Annex 11/15, ICH Q7, and 21CFR Part 11).
• Excellent attention to detail and organizational skills.
• Ability to multi-task and prioritize work tasks with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills
• Competent knowledge and ability to use Microsoft Word and Excel.

Preferred

• Prior experience with the use of an electronic document management system in a regulated environment.

• Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.